None listed
Conditions
Brief summary
This is a trial of a mass drug administration program with ivermectin for community level scabies control in rural north India. This study will be conducted in four villages in the state of Uttarakhand in north India. All residents of the region will be eligible to participate and will be offered two doses of ivermectin seven days apart (or permethrin cream where ivermectin is contraindicated). A skin examination will be performed at baseline and repeated at 12 months. Similar programs have been shown to be very effective in other countries (e.g. Fiji, Solomon Islands) in reducing the rates of scabies in the community. However, these countries have very high rates of scabies in the community at baseline (much higher than in India). This trial aims to assess whether these programs remain effective in areas with a lower baseline prevalence of scabies (estimated 8-9% compared to > 30%).
Interventions
This is an ivermectin-based mass drug administration program
The entire population of the study region will be offered treatment with either oral ivermectin or topical permethrin (where there are contraindications to ivermectin). Two doses of the relevant medication will be provided to each participant (one week apart).
Ivermectin Dose Regime (based on weight)
- 15-25kg - 3.0mg
- 26 - 37.5kg - 6.0mg
- 37.6-50kg - 9.0mg
- 51-75kg - 12.0mg
- > 75kg - 15mg
Contraindications to ivermectin
This is an ivermectin-based mass drug administration program The entire population of the study region will be offered treatment with either oral ivermectin or topical permethrin (where there are contraindications to ivermectin). Two doses of the relevant medication will be provided to each participant (one week apart). Ivermectin Dose Regime (based on weight) - 15-25kg - 3.0mg - 26 - 37.5kg - 6.0mg - 37.6-50kg - 9.0mg - 51-75kg - 12.0mg - > 75kg - 15mg Contraindications to ivermectin include: - Weight under 15kg - Pregnancy - Breastfeeding - Those who are seriously unwell (Unable to engage in normal activities of daily living without assistance because of illness) - People who have previously suffered from a serious adverse event thought to be due to a reaction to ivermectin - People taking warfarin Anyone meeting these criteria will receive 5% permethrin cream. This will be applied all over the body from neck to toe and washed off after a minimum of 8 hours (after 4 hours for children under the age of 2 months). For those receiving ivermectin (the majority of the participants), both doses will be given and directly observed by the study team. Those receiving permethrin will apply this at home in the evening (thus not directly observed). However, they will receive follow up at 1 week when the second dose is administered, at which time the team will be able to provide a reminder to use the cream if they have not already. Skin examinations will be conducted at baseline and then again at 12 months to determine the prevalence of scabies.
Sponsors
The Nossal Institute for Global Health (University of Melbourne)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
Yes
Inclusion criteria
All residents of the study area are eligible to participate in this study
Exclusion criteria
As this is a mass drug administration program, all residents of the selected area are eligible for inclusion in this study. However, the exclusion criteria for drug administration are: - Allergy to any of the components of the allocated drug regimen - Currently on or has taken ivermectin in the previous 7 days - Clinical diagnosis of crusted scabies (will be referred for specialist assessment) These criteria exclude individuals from study drug administration but they remain eligible for inclusion in the study.
Outcome results
None listed